Clinical trials: Serious Adverse Events
Retinal Detachment, Achilles Tendon
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other…
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Trial name
- NCT03479736
- Testing
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Where
- United States
- Volunteers
- 117,911 people
- Sponsor
- Janssen Research & Development, LLC
Hypertension
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- Trial name
- NCT02245464
- Testing
- Telmisartan
- Volunteers
- 13,066 people
- Sponsor
- Boehringer Ingelheim
Unexpected Hospital Mortality, Death, Sudden, Cardiac
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
1. Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's).
- Conditions
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- Trial name
- ALARM (NCT01949025)
- Testing
- ALARM intervention
- Where
- Belgium
- Volunteers
- 69,656 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obesity
Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
It exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be…
- Trial name
- NCT02861092
- Where
- France
- Volunteers
- 76 people
- Sponsor
- Hospices Civils de Lyon
HIV Infections
Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection
This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug.
- Trial name
- NCT00050856
- Testing
- Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Serious Adverse Events, Patient Safety
Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.
- Conditions
- Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
- Trial name
- NCT07592234
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- St Vincent's University Hospital, Ireland
Immunodeficiencies, Primary Immunodeficiencies (PID)
V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency…
- Conditions
- Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia
- Trial name
- VIP (NCT06954441)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Graves Disease
Effective Iodide Therapy for Untreated Patients With Graves' Hyperthyroidism Avoiding Thionamide Drugs With Many Side Effects
As the drug treatment of Graves' hyperthyroidism, Plummer reported the effectiveness of excess iodide in 1923 and iodide was used as the therapy for Graves' hyperthyroidism starting from the 1930s.
- Trial name
- NCT04686006
- Testing
- Potassium Iodide
- Volunteers
- 504 people
- Sponsor
- Kyushu University
Nursing Caries, Critical Care
Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units
Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.
- Trial name
- NURSIE (NCT03475238)
- Testing
- Nursing care
- Where
- 26 sites in Belgium, France and 2 more
- Volunteers
- 262 people
- Sponsor
- French Society for Intensive Care
Drug-Related Side Effects and Adverse Reactions
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine.
- Trial name
- NCT03938597
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Diabetes Mellitus, Type 2
Malignancy Meta Analysis for BRL49653
Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy.
- Trial name
- NCT01195259
- Testing
- allocation of treatment with metformin or rosiglitazone
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
This protocol proposes to investigate genetic factors that may be involved in the pathogenesis of adverse events of interest with selected covid-19 vaccines: vaccine-induced immune thrombotic thrombocytopenia, and neurological…
- Conditions
- Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome, Acute Disseminated Encephalomyelitis, Transverse Myelitis
- Trial name
- NCT05630313
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Bleeding as Complication to Anticoagulation Therapy
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants
Serious adverse events in patients treated with new oral anticoagulants are underreported.
- Trial name
- NCT02107651
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Hvidovre University Hospital
Long-term and Permanent Contraceptive Methods
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar.
- Trial name
- NCT01200576
- Where
- Madagascar
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- FHI 360
Total Knee Arthroplasty, Knee Arthroplasty
Risk of Serious Adverse Events Following Unsupervised vs Supervised Rehabilitation After Knee Arthroplasty
SUMMARY Background: After knee arthroplasty (KA), rehabilitation is widely recommended, yet its clinical effectiveness-especially the need for supervision-has been challenged.
- Conditions
- Total Knee Arthroplasty, Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- Trial name
- SAFE-T (NCT07067060)
- Volunteers
- 40,000 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Sexually Transmitted Diseases
Madagascar Female Condom Study
The study was designed to measure the effects of male and female condom promotion on STI prevalence and reported condom use by sex workers and their partners.
- Trial name
- NCT00272974
- Testing
- Clinic-based counseling
- Where
- 2 sites in Madagascar
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FHI 360
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled.
- Trial name
- NCT01225406
- Testing
- Tenofovir
- Where
- 9 sites in Thailand
- Volunteers
- 56 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Cardiovascular Events, MACE
Tezspire Cardiac Events PASS
The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for…
- Trial name
- TRESPASS (NCT06951867)
- Testing
- Tezepelumab
- Where
- 4 sites in United States, Denmark and 2 more
- Volunteers
- 16,640 people
- Sponsor
- AstraZeneca